# K950239: Sensimatic 500SE

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Jun 6, 1995 after 137 days
- Product code: EKZ (Unit, Electrosurgical, And Accessories, Dental)
- Device class: 2
- Regulation: 21 CFR 872.4920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,329 later devices descend from it; 2 cite it directly.
0 of 1,330 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K962445: Arthrocare Dental Electrosurgery System (1996), 1,325 descendants of its own
- K964849: Arthrocare Dermatologic Electrosurgery System (1997), 1,322 descendants of its own
- K973478: Arthrocare Sinus Electrosurgery System (1998), 1,219 descendants of its own
- K981870: Visage Cosmetic Surgery System (1998), 1,073 descendants of its own
- K000944: Thermage Thermacool System (2000), 1,069 descendants of its own

Source page: https://510kreport.com/device/K950239
Methodology: https://510kreport.com/methodology